Viewing data from:

LITFULO

NDA

RITLECITINIB TOSYLATE | N215830 | PFIZER INC

1 strength3 unique patents1 unique exclusivity

Patent Timeline

3 unique patents, 1 exclusivity by expiration date

Active (3)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

Today

9617258

Dec. 3, 2034

12077533

Dec. 3, 2034

12116368

Oct. 17, 2041

NCE

Jun. 23, 2028

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Litfulo (2023)

Total Spending

$224K

Total Claims

Beneficiaries

Avg Cost/Unit

$142.69

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 26, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 50MG BASE

RLD

3 patents1 exclusivity▴

CAPSULE;ORAL | Approved: Jun 23, 2023

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9617258	Dec 3, 2034	—	Yes	Yes	—	—
12077533	Dec 3, 2034	—	—	—		—
12116368	Oct 17, 2041	—	Yes	—	—	—

Exclusivities (1)

Code	Date	Status
NCE	Jun 23, 2028	Active